Cleared Traditional

K161894 - SurgTech Trauma System

K161894 is an FDA 510(k) clearance for SurgTech Trauma System, manufactured by Surgtech, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K161894 · Surgtech, Inc. · Orthopedic device
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Feb 2017
Decision
225d
Days
Class 2
Risk

K161894 is an FDA 510(k) clearance for the SurgTech Trauma System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Surgtech, Inc. (Westlake, US). The FDA issued a Cleared decision on February 21, 2017 after a review of 225 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgtech, Inc. devices

FDA 510(k) Submission Details - K161894

510(k) Number K161894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2016
Decision Date February 21, 2017
Days to Decision 225 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 122d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Backroads Consulting, Inc.
KAREN E. WARDEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 922
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K161894.
OrthoSolutions 'System26' Bone Screws
K163489 · Ortho Solutions UK Limited · Mar 2017
ToeMATE® Hammertoe Correction System
K170350 · Arthrosurface, Inc. · Mar 2017
EPIC Extremity Snap-Off Screw
K163038 · Epic Extremity, LLC · Feb 2017
DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw
K161616 · Synthes USA Products, LLC · Feb 2017
RASL Repair Kit
K161334 · Radicle Orthopaedics, Inc. · Feb 2017
GEO Bone Screw System
K161904 · Gramercy Extremity Orthopeidics, LLC · Jan 2017